Fluocinolone Acetonide 0.19 mg · intravitreal implant
Injections & Implants, Steroid
Approved uses
Diabetic macular edema, in an eye already shown to tolerate a steroid
One 0.19 mg implant intravitreally, releasing over about 36 months
Reserved for eyes that have already had a steroid without a pressure spike, which the label makes a precondition
Chronic non-infectious uveitis affecting the posterior segment
One 0.19 mg implant intravitreally
Contraindications
Ocular or Periocular Infections Glaucoma Hypersensitivity.
0.19 mg fluocinolone acetonide intravitreal implant in a sterile single-use preloaded applicator with a 25-gauge needle.
Corticosteroids inhibit inflammatory responses to a variety of inciting agents including multiple inflammatory cytokines. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. Corticosteroids are thought to act by inhibition of phospholipase A 2 via induction of inhibitory proteins collectively called lipocortins. It is postulated that these proteins control biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting release of the common precursor, arachidonic acid.
Warnings & Precautions
- Intravitreal injection carries a risk of endophthalmitis, eye inflammation, increased intraocular pressure and retinal detachment; monitor after injection.
- Intraocular pressure increase: prolonged corticosteroid use may raise pressure and cause glaucoma; monitor routinely.
- Cataract: use may lead to posterior subcapsular cataract.
- The implant may migrate into the anterior chamber if the posterior capsule is not intact.
Common Side Effects
The most common adverse reactions reported are cataract development and increases in intraocular pressure.
Pregnancy: No adequate and well-controlled studies in pregnant women; animal reproduction studies have not been conducted with the implant.
Lactation: Unknown whether fluocinolone acetonide is present in human milk after intravitreal use.
The safety and effectiveness of ILUVIEN have not been established in pediatric patients.